BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 9717428 · Received February 17, 2020

    Report

    Report Number
    9616066-2020-00459
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Date of Event
    January 27, 2020
    Report Date
    January 28, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403234316
    PMA / PMN Number
    K820278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT OF A GRAVITY TUBING LEAK AT THE INJECTION PORT WAS CONFIRMED ON THE GRAVITY SET MODEL BY THE RECEIVED CUSTOMER PROVIDED PHOTO. SUSPECT SET MODEL WAS NOT RECEIVED FOR INVESTIGATION. RECEIVED FROM THE CUSTOMER WAS ONE USED GRAVITY SET. CLEAR LIQUID WAS OBSERVED IN THE USED SET¿S DRIP CHAMBER AND ENTIRE LENGTH OF TUBING. NO ABNORMALITIES WERE OBSERVED ON THE SETS DURING VISUAL INSPECTION. FUNCTIONAL TESTING SHOWED NO ANOMALIES. THE ROOT CAUSE OF THE CUSTOMER¿S OBSERVED EVENT WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT OF A GRAVITY TUBING LEAK AT THE INJECTION PORT WAS CONFIRMED ON GRAVITY SET BY THE RECEIVED CUSTOMER PROVIDED PHOTO. SUSPECT SET MODEL 10796812 LOT UNKNOWN, WAS NOT RECEIVED FOR INVESTIGATION. THE ROOT CAUSE OF THE CUSTOMER¿S OBSERVED EVENT WAS NOT IDENTIFIED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A GRAVITY TUBING LEAK. THE EVENT OCCURRED ON A PET/CT UNIT, DURING AN ADMINISTRATION OF "F18 FLUORODEOXYGLUCOSE (RADIOACTIVE FLUORINE)," GIVEN WITH 21 GAUGE NEEDLE USING 3 ML SYRINGE. THERE WAS NO PATIENT HARM OR ADVERSE EFFECTS AS A RESULT OF THIS EVENT. THE EVENT DID NOT CAUSE A SIGNIFICANT CHANGE IN COURSE OF TREATMENT FOR THE PATIENT, NOR REQUIRE MEDICAL OR SURGICAL INTERVENTION AS A RESULT. THERE WAS NO USER HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A GRAVITY TUBING LEAK. THE EVENT OCCURRED ON A PET/CT UNIT, DURING AN ADMINISTRATION OF "F18 FLUORODEOXYGLUCOSE (RADIOACTIVE FLUORINE)," GIVEN WITH 21 GAUGE NEEDLE USING 3 ML SYRINGE. THERE WAS NO PATIENT HARM OR ADVERSE EFFECTS AS A RESULT OF THIS EVENT. THE EVENT DID NOT CAUSE A SIGNIFICANT CHANGE IN COURSE OF TREATMENT FOR THE PATIENT, NOR REQUIRE MEDICAL OR SURGICAL INTERVENTION AS A RESULT. THERE WAS NO USER HARM.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 250ML BRAUN BAG, LOT: J9N180, EXP: 10/21, 0.9% SODIUM CHLORIDE INJECTION; BD CATHETER; TD 01/01/2020 NO PRODUCT WILL BE RETURNED PER CUSTOMER BECAUSE THE PRODUCT WAS DISCARDED. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT DEMOGRAPHICS WERE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A GRAVITY TUBING LEAK. THE EVENT OCCURRED ON A PET/CT UNIT, DURING AN ADMINISTRATION OF "F18 FLUORODEOXYGLUCOSE (RADIOACTIVE FLUORINE)," GIVEN WITH 21 GAUGE NEEDLE USING 3 ML SYRINGE. THERE WAS NO PATIENT HARM OR ADVERSE EFFECTS AS A RESULT OF THIS EVENT. THE EVENT DID NOT CAUSE A SIGNIFICANT CHANGE IN COURSE OF TREATMENT FOR THE PATIENT, NOR REQUIRE MEDICAL OR SURGICAL INTERVENTION AS A RESULT. THERE WAS NO USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180019 ALARIS PUMP MODULE ADMINISTRATION SET SET,ADMINISTRATION,INTRAVASCULAR FPA CAREFUSION 10796812 10885403234316

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR 21 GAUGE NEEDLE,3ML SYRINGE, TD (B)(6) 2020